Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: NIT-OCCLUD SYSTEM
• Generic Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Applicant: Pfm Medical, Inc.; 1916 Palomar Oaks Way Suite 150; Carlsbad, CA 92008
• PMA Number: P120009
• Supplement Number: S002
• Date Received: 12/10/2014
• Decision Date: 01/21/2015
• Product Code: MAE
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
ADDITION OF A NEW PIECE OF EQUIPMENT FOR A MANUFACTURING PROCESS INVOLVING COILING OF WIRE.